Clinical Investigator Training Course

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1 Clinical Investigator Training Course Investigator Responsibilities in Biomedical Research Covered by FDA Regulations Lisa Zimmerman

2 Objectives Discuss Clinical Investigator Obligations according to FDA Regulations Discuss Challenges That Arise in a System of Shared Responsibility Discuss FDA s Bio monitoring Research Program and How to Survive an Inspection 2

3 Starting Point Standards for clinical care of patients Standards for academic research Standards for FDA regulated research 3

4 Clinical Trial Environment Study Subjects Sponsor US FDA OHRP Investigator Institution State IRB 4

5 Federal Legal Framework Federal Food Drug and Cosmetic Act Section 505(i) is the statutory authority for the FDA s oversight of clinical investigations to test safety and effectiveness Code of Federal Regulations (CFR) Describe FDA s authority over the conduct of clinical investigations Sponsor/Investigator responsibilities 5

6 Clinical Trial Regulations Code of Federal Regulations 21CFR11 Electronic records and Signatures 21CFR50 Informed Consent 21CFR54 Financial Disclosure 21CFR56 IRB 21CFR312 Investigational New Drug Applications 21CRF812 Investigational Device Exemptions 6

7 Good Clinical Practice GCP is a living standard and concept and therefore is continually being affected by evolving thoughts and standards There is no perfect Knowledge of GCP!!!! 7

8 Good Clinical Practice GCP is a complicated evolving discipline that intersects with several other complex evolving disciplines, including ethics, medicine and nursing, health systems, regulatory, administrative and case law, information technology, biostatistics, risk analysis, and health policy to name a few 8

9 ICH GCP and FDA GCP 9

10 ICH Guidelines ICH Guidelines are joint guidelines issued by three regions (US, EU, and Japan) They reflect the current thinking in these regions NOTE: Some countries place a little more or less emphasis on the guidelines. If performing international research you must understand the rules of each regions 10

11 ICH Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. (ICH E6) 11

12 FDA GCP Collection of related regulations and guidelines that, when taken together, define the clinical study-related responsibilities of sponsors, clinical investigators, monitors, institutional review boards and others involved in the clinical research process 12

13 FDA GCP Code of Federal Regulations 21CFR11 Electronic records and Signatures 21CFR50 Informed Consent 21CFR54 Financial Disclosure 21CFR56 IRB 21CFR312 Investigational New Drug Applications 21CRF812 Investigational Device Exemptions 13

14 Why Does This Matter FACT : FDA officials emphasize that agency inspectors will inspect sponsors, monitors, and investigators exclusively for compliance with FDA GCP regulations regardless of the GCP standard implemented in the trial 14

15 GCP and Devices CDRH has not formally recognized ICH Guidance in that they have not issued the guidance from the division but they do support adherence to the principles A more relevant guideline for Device Studies is ISO 14155:2011 Clinical Investigation of Medical Devices for Human Subjects - GCP 15

16 FDA Clinical Trial Guidance Generally cuts across all divisionsrepresent FDA s current thinking on Good Clinical Practice and the conduct of clinical trials. All available at guidances/ucm htm 16

17 Available Clinical Trial Guidance 13 general information sheets 6 drug and biologic information sheets 5 Device information sheets 13 general guidance documents 8 IRB guidance documents 16 Drugs and biologic guidance documents 6 Medical device guidance documents 3 Electronic records guidance 3 Manufacturing guidance Approximately 13 draft guidance documents 17

18 THE STATE Welcome to California 18

19 California Health & Safety Code Experimental Subjects Bill of Rights Informed Consent Medical Experiment pertains to drugs and devices Medical Experiments; informed consent Violations; damages; misdemeanor; waiver of rights 19

20 California Health & Safety Code Violations; damages; misdemeanor; waiver of rights Negligent failure to obtain ICF Liable up to$ Willful failure to obtain ICF liable up to $ Willful failure to obtain ICF which exposes the subject to a known substantial risk misdemeanor or fine of $10,000 Any representative or employee of a pharmaceutical company who has knowledge of risks or hazards and withholds the information misdemeanor and/or $10,000 fine 20

21 The Institution STANFORD 21

22 Belmont report California Law: Protection of Human Subjects in Medical Experimentation Act FDA: Food and Drug Administration Informed Consent (guidance) 21 CFR Part 50 - Protection of Human Subjects 21 CFR Part 56 - Institutional Review Boards 21 CFR Part Investigational New Drug Applications (INDs) 21 CFR Part Investigational Device Exemptions (IDEs) Information Sheet Guidances for IRBs, Investigators and Sponsors o Significant Risk and Nonsignificant Risk Medical Device Studies IRB Frequently Asked Questions Clinical Trials and Human Subject Protections - Guidance, resources, good clinical practices (GCPs) OHRP: Office of Human Research Protections Title 45 CFR 46: Protection of Human Subjects Policy guidance and documents Inclusion of Children - Policy Implementation (NIH) Certificates of Confidentiality International Compilation of Human Research Protections - listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations OHRP Frequently Asked Questions VA: Department of Veterans Affairs Office of Research & Development (ORD) Programs 38 CFR Part 16 VA Handbooks website including: o VHA Handbook Requirements for the Protection of Human Subjects in Research o VHA Handbook Research Compliance Reporting Requirements 22

23 For Emphasis Federal Regulations FDA Guidance pertains to the Federal Regulations State Regulations Local regulations FDA audits of sponsors, monitors, and Clinical Investigators based on FDA regulation only 23

24 Responsibilities in Clinical Research According to FDA Regulations and supported by FDA Guidance 24

25 Who is an Investigator? An individual who actually conducts the clinical investigation (under whose immediate direction the drug is dispensed to a subject) If conducted by a team of individuals, the investigator is the responsible leader of the team. [21 CRF 321.3] 25

26 Sponsor-Investigator? An individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed The term does not include any person other than the individual Both Sponsor and Investigator responsibilities [21 CFR 312.3] 26

27 Investigator Responsibilities Ensure investigation is conducted according to the Signed investigator agreement (1572 or Investigator agreement with respect to device) Investigational plan (re. PROTOCOL) Applicable regulation Protecting the right, safety, and welfare of subjects under the investigators care Control of drugs (or devices) under investigation Ensuring that informed consent is adequately obtained according to 21 FR 50 Ensuring IRB review, approval and reporting requirements are met per 21 CFR 56 27

28 Investigators Responsibilities 21 CFR An Investigator shall administer the drug only to subjects under the investigators personal super vision OR Under the supervision of a subinvestigator responsible to the investigator THIS IS A VERY IMPORTANT STATEMENT 28

29 Investigator Responsibilities Control of investigational drug (312.61) Record Keeping and retention Maintain adequate records of the disposition of the drug Accurate case histories that record all observations, and Other data pertinent to the investigation on each individual administered the investigational drug or employed as a control An investigator is required to maintain investigation records for: 2 years following the date a marketing application is approved for the drug for the indication which it is being investigated 2 years after the investigation is discontinued and FDA is notified if no application is to be filed or if the application has not been approved for such indication 29

30 Investigator Responsibilities Progress reports (312.64) Progress to sponsor Safety reports Immediately report serious adverse events Record non serious adverse events and report them to the sponsor according to the timetable for reporting specified in the protocol. DO clarify with the Sponsor what items are considered adverse events as we find the definition can get messy. (especially when inexperience persons are employed on the study) Final report to sponsor Financial disclosure to sponsor (21 CFR 54) 30

31 Investigator Responsibilities Guidance (CDER, CBER, CDRH) FDA final guidance document issued October 2009 Guidance covers: Appropriate delegation of study tasks Appropriate training of study staff Supervision of staff, including contracted personnel Subject protections, including necessary medical care 31

32 IRB Review FDA Guidance (Including ICH E6) require submission of: Consent documents Protocol/amendments Advertisements Written information provided to the subjects Investigators brochure Investigators CV and/or qualifications Progress reports and reports of injuries 32

33 Supervision For both Drugs and Device the investigator commits themselves to personally conduct or supervise the investigation Note: FDA Knows It is common practice for PI to delegate certain study tasks to employees, colleagues, or other third parties (individuals who are not under the direct supervision of the PI) Source 2009 guidance 33

34 Supervision When the tasks are delegated by the PI, the PI is responsible for providing adequate supervision of those to whom tasks are delegated. The PI is accountable for regulatory violations resulting from failure to adequately supervise Source 2009 guidance 34

35 Appropriate Delegation Any individual to whom a task is delegated must be qualified by education, training, and experience (and state licensure where relevant) Individuals delegated must meet any protocol specified requirements Listing of tasks and individuals delegated should be maintained Source 2009 guidance 35

36 Appropriate Delegation Appropriate delegation is more of an issue for tasks considered to be clinical or medical in nature Evaluating study subjects to assess clinical response Providing medical care during the study 36

37 Delegation Issues and Discussion FDA common observations Individuals not qualified to conduct: Screening evaluations (incl. Medical history and assessment of inclusion/exclusion criteria) Physical exams Evaluation of adverse events Assessment of primary study endpoints Obtaining informed consent Source 2009 guidance 37

38 Common Mistake Areas Medical History Relevant Medical History Concomitant Medications Adverse events vs. Current medical conditions Lack of understanding of primary endpoints and how the protocol supports them 38

39 FDA Observations - Supervision Factors that affect ability to provide adequate supervision Inexperienced study staff Demanding workload of study staff Complex trials Large number of subjects enrolled at site Subject population is seriously ill 39

40 FDA Observations - Supervision Conducting multiple studies concurrently Conducting study from remote locations Conducting a study at multiple sites under oversight of single investigator 40

41 Helpful Hints: Have a PLAN Routine meetings with staff Routine meetings with monitors YES I said that Procedures for correction and documentation of problems identified by study personnel Procedures for ensuring proper consent Procedures for ensuring data accuracy 41

42 Have a PLAN - continued Procedures for dealing with data queries (this can be challenging between sponsors so you dictate the plan to them!) Procedures for ensuring compliance with protocol, adverse event assessment and reporting requirements Procedures for addressing medical and ethical issues 42

43 Investigator Responsibilities FOLLOW THE PROTOCOL Failure to follow the protocol (otherwise known as protocol deviations or violations) has been on FDA s top ten list ever since the BIMO inspection program started in Last year this was an issue in almost 40% of the inspections 43

44 Violations/Deviations Prospective action before making a deviation is preferred. Call Sponsor and the IRB Violations after the fact should be identified immediately Violations/deviations can cause harm to the subject and/or make it difficult to assess the study endpoints 44

45 Investigator Responsibilities Subject protections, including necessary medical care Reasonable medical care for study related medical problems Provision of access to appropriate medical care when specialized care is required Adherence to study protocol is also considered a protection with respect to not exposing subject to unreasonable medical risks Protocol violations can also be considered failure to protect 45

46 Regulatory Documents THE FACTS 46

47 Statement of Investigator What is it? Form FDA 1572 This is an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with the FDA regulations related to the conduct of a clinical investigation of an investigational new drug or biologic NOTE: This form is NOT used for studies involving devices 47

48 The

49 The

50 Device Studies? The sponsor should develop an investigators agreement which includes the elements of 21 CFR (c). Very similar language to the form FDA 1572 The sponsor should have all investigators sign the agreement prior to participating in the study. 50

51 CVs CVs for PI is required to show proper education and training to perform the study CV s for sub-investigators are collected to ensure that they are qualified to perform their functions with respect to the clinical investigation CV s do not have to be signed and dated. It is not a requirement 51

52 Other Regulatory Documents Financial disclosure IRB Information Lab Information PI license - If applicable Protocol/amendment signature pages IRB approvals of study and associated documents/processes 52

53 Sponsor Responsibilities Select qualified investigators (21 CFR ) Design, conduct, perform, monitor, audit, record, analyze, and report clinical trials such that that they can provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects have been protected. 53

54 FDA s Responsibilities In Regulated Research Protect the rights and welfare of human research subjects Assure the quality and integrity of bioresearch data Ensure compliance with regulatory requirements 54

55 Moral of the Story It takes a village 55

56 56

57 Section II THE FDA AUDIT 57

58 FDA Oversight BIMO Inspection Program In 1977 the Bioresearch Monitoring Inspection Program was developed to assure quality and integrity of data and to determine that the human rights and welfare of human and animal subjects are adequately protected. 58

59 FDA Bioresearch Monitoring Program Inspections of clinical investigators, sponsors, IRB, GLP facilities and Bioequivalence studies Investigator shall permit the FDA to have access to, and copy and verify any records or reports made by the investigator (312.68) Types of Inspections Data validation in support of new drug application (NDA) or PMA For Cause (compliance) Surveillance 59

60 BIMO Inspections Center Clinical Investigator IRB Sponsor/ Monitor CBER CDER CDRH

61 BIMO Inspection Program Compliance Guidance Program Manual The SOP for Inspections 21 CFR CFR CFR CFR CFR CFR CFR 314 and 814 NDA and PMA 61

62 The Process Notice of Inspection Inspections can be announced or unannounced Clinical Investigators must allow FDA to access, copy, and verify any records or reports made by the CI with regard to, among other records, the disposition of the investigational product and subject case histories 62

63 Typical FDA Inspector Questions During Interview Delegation of Authority who, when, where Screening of subjects Interpreting screening results/admitting to the study Informed consent of subjects (the process) Receipt of test article; handling; administration; return Reporting (including safety reporting)/transcribing data Clinical Laboratory (who evaluates the results? when?) Training (Is this real training or just for show) Archiving of study data 63

64 The FDA Inspection is not a scientific review of the data or the protocol 64

65 During the Inspection Do: Provide inspector with what they ask for. Answer the inspector s questions concisely and do not volunteer additional information Provide the inspector with adequate space DO NOT provide documents or information that they do not ask for 65

66 After The Inspection FDA Inspector conducts an exit interview. Outcomes can be: No Action Indicated or If Inspector finds deficiencies with respect to regulations he/she issues a written Form FDA 483 (Inspectional Observations) If the Inspector is issuing a 483, this is the time to engage in a verbal discussion about the findings 66

67 Form FDA 483 Response Again - Engage in verbal discussion at closeout This is not a blame session. As the PI is your responsibility to adhere to your obligations. The inspector is issuing findings based on what they have that was available to the PI. Send written response within 15 days 67

68 483 Response The written response This is an opportunity to explain. In the event that the PI failed to adhere to the regulations, the Principle Investigator must submit a corrective action plan with real and specific corrective actions...we will do better next time will earn you a Warning letter 68

69 Most Common Deficiencies Same since the BIMO program started Failure to follow the investigational plan and/or regulations (40%) also know as Protocol violtions/deviations Inadequate record keeping (26%) Inadequate accountability for the investigational product (9%) Inadequate communication with the IRB (7%) Inadequate subject protection failure to report AEs and informed consent issues (1%) 69

70 Common Causes Poor supervision and training of study staff Insufficient investigator involvement in study conduct Inappropriate delegation of study tasks to unqualified persons Failure to adequately protect study subjects Overworked investigator and study staff (too many subjects, complex study with large data collection, too many concurrent studies) 70

71 FDA Compliance Classifications NAI No Action Indicated VAI Voluntary Action Indicated Minor deviations(s) from regulations Voluntarily correction is requested OAI Official Action Indicated Serious non-compliance requiring regulatory or administrative action by FDA 71

72 Clinical Investigator Inspections FY

73 Regulatory Actions Warning Letter Notice of Disqualification Proceedings and Opportunity to explain (NIDPOE) Disqualification Criminal investigations by Office of Criminal Investigations (OCI) Debarment 73

74 Case 1: Dr. Holland - Lax supervision Study Coordinator enrolled ineligible subjects in oncology trials Coordinator altered source records and created fraudulent CRFs to make subjects appear eligible Data manipulations should have been apparent to attentive clinician Subject who was ineligible due to poor renal and liver function was enrolled and died as a result Study coordinator sentenced to 71 months in prison and debarred from any future involvement in FDA regulated research Dr. Holland-5 years probation, $500k restitution, disqualified 74

75 75

76 Case #2 Dr. Palazzo The defendant agreed to conduct Studies 704 and 716 in accordance with the protocol and to only make changes in the protocol after notifying the sponsor or, if necessary for the safety of the subject The defendant also agreed to personally conduct or supervise the investigation and to maintain adequate and accurate records in accordance with 21 CFR , and to comply with all other obligations of clinical investigators found in 21 CFR 312 At the bottom of each Form 1572 was a warning that statement on the form had to be truthful and if found not to be, could result in a prosecution for false statement to a government agency 76

77 Case #2 - Palazzo Study records indicated that Dr. Palazzo Included psychiatric diagnosis inconsistent with patients psychiatric histories; Prepared multiple psychiatric evaluations on study patient which contained different diagnoses and treatment plans; Reported symptoms of OCD when the study subject did not demonstrate such symptoms; and Examined study subject when she had not Sentenced to thirteen (13) months in prison 77

78 Warning Letters Of Note Lobo 2014 Columbia University Medical Center -Dr. Lobo as the Sponsor You failed to ensure proper monitoring including: Failure to identify that the Investigator did not obtain informed Consent for 28 out of 50 subjects Failure to identify that the IRB approval had lapsed from March 31 to June 3 Four subjects were not dosed according to the protocol 78

79 Warning Letters and the Corrective Action Plans Recent Warning letters have sited inadequate corrective action plans. (i.e. no real tangible plan) Dr. Lobo Columbia Dr. Zimmerman - Columbia Frazer Byrzunski 79

80 How can clinical investigators ensure high quality data and subject safety? Create systems that limit opportunity for errors Select qualified staff and ensure adequate training and supervision Ensure staff are not performing tasks they are not qualified to do (assessing eligibility, physical exams, assessing AEs) Ensure oversight of sub investigators and study staff 80

81 How can clinical investigators ensure high quality data and subject safety? Implement system to detect and correct errors in real time Pay attention to monitoring queries and respond promptly Audit trail of changes should make clear what was changed, who changed it, and why it was changed Evaluate need for system wide corrections and training 81

82 Improve Process Be Proactive Address human factors in systems Hire experienced, qualified staff Avoid conflicts of interest/ financial incentives Decrease number of times data are handled Assess ability to comply with protocol visits; laboratory testing; electronic systems for data capture; archiving and transmission to sponsor; maintaining records; drug accountability 82

83 Improve Process Be Proactive Create systems that limit opportunity for errors Simplify protocol and outcomes assessed Be realistic about the amount of data to be collected Standardize systems and formats where possible Use validated instruments/definitions Write down all procedures 83

84 Improve Process- Be Proactive Don t re-invent the wheel Keep amendments to a minimum and check CRFs and consent against each change 84

85 Improve Process Data and safety monitoring plan, data management plan, Quality Assurance Plan, Data Analysis Plan Insist on training and then test it Think carefully about un-blinding procedures Have weekly team meetings Audit yourself be open and honest 85

86 Implement system to Detect Errors Do real time cleaning of the data Pay attention to monitoring queries and respond promptly close the loops Audit trail of changes should make clear what was changed, who changed it, and why it was changed Evaluate the need for system wide corrections and training 86

87 Key Points Clinical Investigators play a key role in ensuring high quality studies Good care of patients is not the same as Good Clinical Practice in research Ensure that all staff have a clear understanding of responsibilities under the FDA regulations 87

88 At stake is the public confidence and participation in the clinical trials and ultimately the availability of safe and effective products 88

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